Regulatory Submissions (Study Start-up) Manager
International Careers
Req #: 11394
Type: Full-Time
|
|
|||||||||||
|
||||||||||||
Overview: Medpace is a full-service clinical contract research organization (CRO). We provide Phase I-IV clinical development services to the biotechnology, pharmaceutical and medical device industries. Our mission is to accelerate the global development of safe and effective medical therapeutics through its scientific and disciplined approach. We leverage local regulatory and therapeutic expertise across all major areas including oncology, cardiology, metabolic disease, endocrinology, central nervous system, anti-viral and anti-infective. Headquartered in Cincinnati, Ohio, employing more than 5,000 people across 40+ countries. Responsibilities: * Experience with direct communication with MFDS, liaising between the local authorities and Sponsors to solve queries and expedite local approvals; * Regional experience efficiently managing and successfully executing all aspects of regional start-up in APAC region; * Review pertinent regulations to develop proactive solutions to start-up issues and challenges; and * Present during bid defenses, general capabilities meetings, and audits. Qualifications: * More than 5 years of experience in clinical research, preferably with a CRO. Experience may include CRA or project management experience; * Possess Regulatory background/ strong scientific technical knowledge * Regional experience will be highly advantageous; * Excellent English oral and written communication skills. Travel: Minimal
Share this job:
